J065--Prevacuum Sterilizer cleaning and Medical/Dental Instrument Inspection, Sharpening, Maintenance and Repair Services for Clement J. Zablocki VAMC located in Milwaukee, WI and Milo C Huempfner Outpatient Clinic, Green, WI.

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Contract Opportunity

VENDOR QUESTIONS/ANSWERS
As we work to finalize our quotation for RFQ 36C25226Q0299, we would like to request clarification regarding acceptance of equivalent or higher-level quality certifications for two requirements in the Performance Work Statement:

1. ISO 9001 / ISO 13485 Requirement

The PWS states that the contractor must hold ISO 9001 and ISO 13485 certifications.
Agiliti holds ISO 13485, which incorporates and exceeds the ISO 9001 quality management system requirements. ISO 13485 is built upon the full ISO 9001 framework and includes all applicable 9001 principles within its scope.

Request: Will the Government accept ISO 13485 in place of holding both certifications separately?

Yes
2. ASQ / CQI Technician Certification Requirement
The PWS states that technicians must possess ASQ and CQI certifications.
Our personnel hold ISO Quality Auditor Certification, which provides a more advanced level of competency than ASQ or CQI, including auditing, process validation, quality system evaluation, and compliance assessment.

Request: Will the Government accept ISO Quality Auditor Certification as an equivalent or higher-level qualification for meeting the ASQ/CQI requirement?
Yes

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